NOTICE
ANSM - Last updated: 05/04/2016
Name of the medicinal product
SYNTHOL gel
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 5 days.
Do not use this medication for children.
Review summary
In this notice :
1. WHAT IS SYNTHOL, GEL AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE SYNTHOL, GEL?
3. HOW TO USE SYNTHOL, gel?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SYNTHOL, gel?
6. ADDITIONAL INFORMATION
1. WHAT IS SYNTHOL, GEL AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
OTHER TOPICS FOR ARTICULAR AND MUSCULAR PAIN; ATC code: M02AX10.
Therapeutic indications
In adults and children over 7 years of age, this medication is recommended for local treatment of benign trauma (blues, strokes).
2. BEFORE YOU USE SYNTHOL, GEL?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use SYNTHOL, gel:
· If you are allergic (hypersensitive) to levomenthol, veratrole, resorcinol, salicylic acid, near active substances or any of the other ingredients of this medication mentioned in section 6.
· If you have a history of allergies to salicylates, a related drug (NSAIDs, aspirin) or any of the other ingredients,
· In children and elderly subjects with a history of convulsions (febrile or not), due to the presence of terpene derivatives (levomenthol, lavandin essential oil and linalool).
Do not apply to the eyes, on damaged skin regardless of lesion: oozing lesions, eczema, infected lesion, burn or wound.
Precautions for use; special warnings
Warnings and Precautions
Talk to your doctor or pharmacist before using SYNTHOL, gel.
This medication is reserved for adults and children over 7 years of age.
This specialty contains terpenic derivatives (levomenthol, essential oil of lavandin and linalool) which can lead to excessive doses of seizure-type accidents in children. Observe the instructions for use:
· do not use in children under 7 years,
· never apply a dose higher than recommended (see section "3. How to use SYNTHOL gel"),
· do not apply over an extended surface of the body,
· respect the recommended frequency and duration of treatment.
In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR.
After application, it is necessary to wash your hands to avoid any involuntary contact of the product with the eyes.
Interaction with other medicines
Other medicines and SYNTHOL gel
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
In case of breast-feeding, it is preferable not to use this medication and in no case should it be applied to the breasts.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
SYNTHOL, gel contains alcohol
3. HOW TO USE SYNTHOL, gel?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
1 application on the painful area 2 to 3 times a day.
Wash hands after application
Administration mode
Dermal
Duration of treatment
If there is no improvement after 5 days of treatment, consult your doctor.
Symptoms and Instructions for Overdose
If you used more SYNTHOL, freeze than you should:
Rinse thoroughly with water.
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to use SYNTHOL, gel:
Do not take a double dose to make up for the single dose that you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Risk of local reaction.
· Rare cases of contact dermatitis requiring discontinuation of treatment have been reported.
· Possibility of skin redness at the point of application.
· Due to the presence of terpene derivatives and in case of non-respect of the recommended doses:
o risk of convulsions in children,
o possibility of agitation, confusion in the elderly
Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, please tell your doctor or pharmacist.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE SYNTHOL, gel?
Keep out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Storage conditions
This medication should be stored at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What SYNTHOL contains, gel:
The active substances are:
Levomenthol ................................................. .................................................. .................................. 0.520 g
Veratrole ................................................. .................................................. ....................................... 0.250 g
Resorcinol ................................................. .................................................. ..................................... 0.030 g
Salicylic acid................................................ .................................................. ............................. 0.100 g
For 100g of gel
The other components are:
Aromatic composition (linalyl acetate, lavandin essential oil, linalol, coumarin, geraniol) benzyl alcohol, hydroxyethylcellulose, citric acid monohydrate, Macrogol lauryl ether, 96% ethanol, purified water.
Pharmaceutical form and content
Aspect of SYNTHOL, gel and contents of the pack
This medication is in the form of a gel. Tube of 75 g and 100 g.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 ROUTE OF VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
exploiting
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 ROUTE OF VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
Maker
BOOTS COMPANY PLC
BEESTON SITE THANE ROAD
NOTTINGHAMSHIRE NG2 3AA
UK
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was revised is the MM / YYYY.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
ADVICE / HEALTH EDUCATION
OTHER TOPICS FOR ARTICULAR AND MUSCLE PAIN
You just have a mild trauma or a bruise, you can use the gel to relieve your pain.
However, if there is a complete functional impairment, ie if you can not use the upper limb or the lower limb and in case of a large (blue) hematoma, you should also consult without delay your doctor.